Surgical closure disk and balloon method

ABSTRACT

A surgical closure device comprises an elongate tubular member having a balloon attached in a collapsed configuration to the tubular member at the distal end thereof. A disk is attached to the tubular member at the distal end thereof, proximally of the balloon. During a surgical operation, the distal end of the instrument, including the balloon but not the disk, is inserted through a perforation in an internal body organ of a patient. The balloon is inflated while inside the organ and presses a wall of the organ against the disk to effectively close the perforation. The tubular member may then be subjected to a suction force to enable evacuation of liquid from the organ. After the suctioning operation, the tube is clamped and severed, the balloon remaining at least temporarily attached to the organ.

This application is a continuation-in-part of copending application Ser.No. 803,582 filed Dec. 9, 1991 (now U.S. Pat. No. 5,211,624).

BACKGROUND OF THE INVENTION

This invention relates to a surgical closure device. This invention alsorelates to a surgical method utilizing the closure device. The closuredevice and associated method are particularly useful in laparoscopicsurgery.

Laparoscopy involves the piercing of the abdominal wall and theinsertion of a tubular port member through the perforation. Variousinstruments may be inserted through the tubular member to performsurgical operations inside the abdomen.

Generally, upon the disposition of the first tubular member so that ittraverses the abdominal wall, the abdominal cavity is pressurized todistend the abdominal wall and provide a safety region between the walland the body organs inside the cavity. Moreover, several perforationsare made. One perforation receives a laparoscope which enables visualmonitoring of organs and surgical activities inside the abdominalcavity. Other perforations serve for the insertion of different surgicalinstruments.

Laparoscopic surgery provides several advantages over conventionalincision-based surgery. The laparoscopic perforations, in beingsubstantially smaller than the incisions made during conventionaloperations, are less traumatic to the patient and provide for anaccelerated recovery and convalescence. Hospital stays are minimized.Concomitantly, laparoscopic surgery is less time consuming and lessexpensive than conventional surgery for correcting the same problems.

Laparoscopic surgery frequently requires the temporary closure ofperforations in internal organs and body tissues. Such closure is insome cases especially critical. For example, if a gall bladder isinadvertantly perforated during dissection thereof in laparoscopicsurgery, bile is spilled, which potentially contaminates other organsand tissues in the abdominal cavity. It is imperative, therefore, thatthe perforation be closed immediately.

In a conventional technique for closing a perforated gall bladder, aclamp is attached to the organ at the perforation. A loop is then passedaround the clamp and drawn shut. This technique is difficult and timeconsuming. Moreover, a significant quantity of bile generally escapesthe bladder into the abdomen.

Another kind of surgery requiring closure of perforations in internalorgans arises where a patient is a victim of violence. In such cases oftrauma, it frequently happens that many organs have perforations throughwhich blood flows at a high rate into the patient's abdominal cavity.The closure of such wounds must be effectuated as quickly andefficiently as possible to minimize blood loss and trauma to thepatient.

OBJECT OF THE INVENTION

An object of the present invention is to provide a closure device whichfacilitates surgical closure operations.

Another object of the present invention is to provide such a closuredevice which can be used in laparoscopic surgery to close wounds orperforations in internal body organs of a patient.

Another, more particular, object of the present invention is to providesuch a closure device which is easy and quick to use.

A further object of the present invention is to provide a new method forat least temporarily closing openings in a patient's internal bodyorgans and tissues.

SUMMARY OF THE INVENTION

A surgical closure device comprises, in accordance with the presentinvention, an elongate rod-like member having a distal end, a proximalend, a longitudinal axis, and a balloon attached in a collapsedconfiguration to the rod-like member at the distal end thereof. Theballoon is expandable from the collapsed configuration to an expandedconfiguration by an inflation mechanism or component operativelyconnected to the balloon. A disk is attached to the rod-like member atthe distal end thereof, proximally of the balloon. The disk extendssubstantially transversely to the longitudinal axis of the rod-likemember and is spaced from the balloon so as to enable a clamping of anorganic membrane between the disk and the balloon upon an expansionthereof by the inflation component.

Pursuant to another feature of the present invention, the rod-likemember is hollow and thereby takes the form of a tube. In addition,components are provided for subjecting the tube to a vacuum, therebyproviding an evacuating suction force at the distal end. This feature ofthe invention enables, for example, bile to be removed from a gallbladder upon the sealing of a perforation in the bladder by the inflatedballoon and the disk.

Preferably, the tube is made of a deformable material. In that event,upon the inflation of the balloon and the consequent sealing of theopening at which the balloon and the disk are disposed, and possiblyafter the evacuation of the respective organ through a suctioningoperation as described above, the tube may be closed and severed. If theorgan is being removed from the body, then the balloon closure devicemay be retained in the opening during the removal of the organ.

Pursuant to an additional feature of the present invention, the expandedconfiguration of the balloon is substantially annular. Accordingly, theballoon defines a center hole, the rod-like member traversing the centerhole of the balloon.

Pursuant to another feature of the present invention, disk is asubstantially rigid member.

A surgical closure method comprises, in accordance with the presentinvention, the steps of (a) providing an elongate rod-like memberprovided at a distal end with an expandable balloon in a collapsedconfiguration and a substantially rigid disk located proximally of theballoon, (b) inserting the distal end of the rod-like member and theballoon through an opening in a selected internal body organ or tissueof the patient, (c) maintaining the disk on an outer side of theinternal body organ or tissue of the patient during the step ofinserting, and (d) inflating the balloon from the collapsedconfiguration to an expanded configuration so that a portion of theselected internal body organ or tissue is sandwiched between the balloonand the disk, thereby at least temporarily closing the opening.

Where the rod-like member is hollow and takes the form of a tube, thesurgical closure method further comprises the step of applying suctionto the tube upon the inflation of the balloon. In addition, the tube maybe crimped and severed upon completion of the suction application step.The severing of the tube removes the shaft of the tube from the surgicalsite and thus provides more space for other procedures in the event, forexample, that the method is being used during abdominal surgery. Duringlaparoscopic surgery, the removal of the proximal end portion of thetube frees a trocar sleeve for the insertion of another instrument.

In abdominal surgery, a distal portion of the rod-like member isinserted into a patient's abdominal cavity, through an aperture in anabdominal wall of a patient, prior to the insertion of the distal end ofthe rod-like member and the balloon through an opening in a selectedinternal body organ or tissue of the patient. In the more specializedcase of laparoscopic surgery, a laparoscopic trocar sleeve is disposedin the aperture in the abdominal wall of the patient at the onset of thesurgical procedure, the distal portion of the rod-like member beinginserted through the trocar sleeve into the patient's abdominal cavity.

A method in accordance with the present invention is particularly usefulin laparascopic surgery. In such a procedure, a distal portion of therod-like or tubular member is inserted into a patient's abdominalcavity, through an aperture in an abdominal wall of a patient, prior tothe step of inserting the distal end of the rod-like member and the oneof the balloons only through an opening in a selected internal bodyorgan or tissue of the patient.

A surgical method and closure device in accordance with the presentinvention is useful in trauma cases to quickly close wounds throughwhich blood is flowing out of the patient or into an internal bodycavity. The closure devices remain temporarily in place until each ofthe individual wounds can be closed separately by conventionaltechniques.

A closure device and associated method in accordance with the presentinvention facilitates surgical closure operations and is particularlyeffective in laparoscopic surgery to close wounds or perforations ininternal body organs of a patient. Of course, the clamping disk islimited in diameter by the size of the respective trocar sleeve andparticularly by the diameter of the port at the proximal end of thesleeve.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a side elevational view of a surgical closure device, showinga pair of balloons in a collapsed configuration.

FIG. 2 is a side elevational view of the surgical closure device of FIG.1, showing the balloons in an inflated or expanded configuration.

FIGS. 3A-3F show successive steps in the use of the closure device ofFIGS. 1 and 2 to close a perforation in a gall bladder in a laparoscopicprocedure.

FIG. 4 is a side elevational view of a surgical closure device inaccordance with the present invention, showing a balloon in a collapsedconfiguration and a disk at the distal end of a rod or tube.

FIG. 5 is a side elevational view of another surgical closure device inaccordance with the present invention, showing a balloon with a pair ofintercommunicating lobes in a partially expanded configuration.

DETAILED DESCRIPTION

As illustrated in FIGS. 1 and 2, a surgical closure device 20 comprisesa rod-like body member 22 in the form of an elongate substantially rigidtube. Two hollow conduits 24 and 26 are fastened to tube 22 via aplurality of clamping rings 28 and 30. Conduits 24 and 26 accordinglyextend parallel to tube 22 from a proximal end of the instrument, wherethe conduits have end portions 24a and 26a which diverge from tube 22 tofacilitate attachment of the conduits to a source of pressurized air 32.

At a distal end, conduits 24 and 26 communicate with respective annularballoons 34 and 36 which are initially in a collapsed or deflatedconfiguration, as illustrated in FIG. 1. Balloons 34 and 36 are attachedto tube 22, tube 22 traversing holes (not illustrated) at the centers ofthe balloons. Under the control of a valve assembly 38 which isconnected between pressurized air source 32 and the proximal endportions 24a and 26a of conduits 24 and 26, balloons 34 and 36 areinflatable from the collapsed configuration of FIG. 1 to an expanded useconfiguration depicted in FIG. 2. In the expanded configuration,balloons 34 and 36 press tightly against one another along a contactplane 40.

Tube 22 is connectable at a proximal end to a suction device or vacuumgenerator 42, whereby a fluid or fluidized substance (liquid, gas,emulsion, suspension, powder, etc.) may be evacuated from a space at thedistal end of tube 22.

It is to be noted that the structural relationship among tube 22 andconduits 24 and 26 may be varied within the scope of the invention. Forexample, conduits 24 and 26 may be located within tube 22 or may beformed by partitions inside tube 22. Alternatively, conduits 24 and 26may be flexible tubular members generally separate from tube 22 andconnected to tube 22 only indirectly via balloons 34 and 36 at thedistal end of tube 22.

It is to be further noted that tube 22 is preferably rigid at leastalong a proximal end portion. At the distal end, tube 22 may bepartially flexible to facilitate positioning and installation ofballoons 34 and 36 at a perforation in an internal body organ of apatient. In that event, the closure device is provided with a pluralityof tensioning cables (not shown) or other means for varying theorientation of the distal end of the instrument relative to the proximalend.

FIG. 3A shows a gall bladder 44 with a perforation or opening 46. Bileis flowing out of the bladder, as indicated by an arrow 48.

As illustrated in FIG. 3B, closure device 20 is partially inserted intothe abdominal cavity AC of a patient P through a tubular port member 50which is disposed in an opening (not visible) formed in the abdominalwall AW of the patient, for example, through the use of a trocar. Thedistal end of closure device 20 is inserted through opening 46 so thatballoon 36 (located distally of balloon 34) is inserted into the bladder44, while balloon 34 remains outside of the bladder. Conduit 26 is thenconnected to pressurized air source 32 (FIG. 2) via the opening of avalve in valve assembly 38, which pressurizes and inflates balloon 36from the collapsed configuration of FIG. 1 to the expanded configurationshown in FIGS. 2 and 3B.

It is to be noted that pressurized air source 32 may take the form of aperson's lungs, while control valves or valve assembly 38 includes theperson's throat and/or lips. In addition, balloons 34 and 36 may beprovided with one-way flow control valves (not illustrated) to preventair from leaving the balloons once they are inflated. To deflateballoons 34 and 36 in that case, the operating surgeon need only piercethem with a scalpel or other sharp instrument.

FIG. 3C depicts a subsequent stage in the laparoscopic operationutilizing the closure device of FIGS. 1 and 2. As shown in FIG. 3C,conduit 24 has been connected to pressurized air source 32 (FIG. 2) viathe opening of a valve in valve assembly 38. Balloon 34 is thus inflatedand presses against balloon 36 so as to tightly sandwich the wall ofgall bladder 44 and effectively close opening 46.

Upon the completed inflation of balloons 34 and 36, bile is aspiratedfrom bladder 44, for example, through the connection of the proximal endof tube 22 to suction device 42 (FIG. 2) or through the insertion ofanother, thinner tube 52 through tube 22, as illustrated in FIG. 3D.Inner tube 52 is connected at a proximal end to a manually actuatablehypodermic syringe 54 or other source of underpressure.

Upon the completion of the suctioning operation, tube 22, as well asconduits 24 and 26, is closed at a point proximally located with respectto proximal balloon 34. This closure of tube 22 is effectuated with theaid of a clamping forceps 56 partially inserted into abdominal cavity ACthrough a second tubular port member 58 traversing abdominal wall AW. Tofacilitate a crimping of tube 22 by clamping forceps 56, at least aportion of tube 22 proximate to balloon 34 and located proximallythereof is made of a deformable material.

Upon a crimping of tube 22 (and optionally conduits 24 and 26), clampingforceps 56 is removed from abdominal cavity AC and a cutting forceps 60is inserted for severing tube 22 and conduits 24 and 26 at a pointlocated proximally with respect to the crimp, as shown in FIG. 3E.Cutting forceps 60 and the severed proximal end portion 20' of closuredevice 20 are then removed from abdominal cavity AC via port members 58and 50, respectively. Balloons 34 and 36 remain attached at leasttemporarily to bladder 44, as illustrated in FIG. 3F, to maintainclosure on perforation or opening 46.

As illustrated in FIG. 4, a surgical closure device 70 comprises arod-like body member 72 in the form of an elongate substantially rigidtube. A hollow conduit 74 is fastened to tube 72 via a plurality ofclamping rings 76. Conduit 74 extends parallel to tube 72 from aproximal end of the instrument, where the conduit has an end portion 74awhich diverges from tube 72 to facilitate attachment of the conduits toa source of pressurized air 80.

At a distal end, conduit 74 communicates with an annular balloon 78which is initially in a collapsed or deflated configuration. Balloon 78is attached to tube 72, while tube 72 traverses a hole (not illustrated)at the center of the balloon. A pressurized air or saline solutionsource 80 is connected to conduit 74 at a proximal end thereof forexpanding balloon 78 from the collapsed configuration of FIG. 1 to anexpanded use configuration. In the expanded configuration, balloon 78presses tightly against a substantially rigid disk 82 attached to tube72 at a distal end thereof, proximally of balloon 78. Disk 82 has adiameter sufficiently small to enable the insertion of the distal endportion of the closure device 70 through a laparoscopic trocar sleeveduring a laparoscopic procedure.

Tube 72 is connectable at a proximal end to a suction device or vacuumgenerator 84, whereby a fluid or fluidized substance (liquid, gas,emulsion, suspension, powder, etc.) may be evacuated from a space at thedistal end of tube 72.

Conduit 74 may be located within tube 72 or may be formed by partitionsinside tube 72. Alternatively, conduit 74 may be a flexible tubularmember generally separate from tube 72 and connected to tube 72 onlyindirectly via balloon 78 at the distal end of tube 72.

It is to be further noted that tube 72 is preferably rigid at leastalong a proximal end portion. At the distal end, tube 72 may bepartially flexible to facilitate positioning and installation of balloon78 at a perforation in an internal body organ of a patient. In thatevent, the closure device is provided with a plurality of tensioningcables (not shown) or other means for varying the orientation of thedistal end of the instrument relative to the proximal end.

The use of closure device 70 is substantially similar to the use of thedevice of FIGS. 1 and 2. Use of closure device 70 is clear from thedescription hereinabove with reference to FIGS. 3A-3F.

As illustrated in FIG. 5, a surgical closure device 86 comprises arod-like body member 88 in the form of an elongate substantially rigidtube. A hollow conduit 90 is fastened to tube 88 via a plurality ofclamping rings 92. Conduit 90 accordingly extends parallel to tube 88from a proximal end of the instrument. At a distal end, conduit 90communicates with a balloon 94 having a pair of annular lobes 94a and94b connected to one another via an annular duct 96 or by a part ofconduit 90. Annular balloon lobes 94a and 94b are initially in acollapsed or deflated configuration (compare FIG. 1). Duct 96 may beformed integrally with lobes 94a and 94b , as a unitary part of balloon94.

Upon a pressurization of balloon 94, lobes 94a and 94b inflatesubstantially simultaneously to press or clamp an organic tissuemembrane and thereby close a perforation through which the distal end oftube 88 and lobe 94a have been inserted during a surgical closureoperation.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proferred by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A surgical closure method, comprising the stepsof:disposing a laparoscopic trocar sleeve in an aperture in an abdominalwall of a patient; providing an elongate rod-like member provided at adistal end with an expandable balloon in a collapsed configuration and asubstantially rigid disk located proximally of said balloon; moving saiddistal end of said rod-like member, said balloon in said collapsedconfiguration and said disk through said trocar sleeve into thepatient's abdominal cavity; subsequently inserting said distal end ofsaid rod-like member and said balloon through an opening in a selectedinternal body organ or tissue of the patient inside said abdominalcavity; maintaining said disk on an outer side of said internal bodyorgan or tissue of the patient during said step of inserting; andinflating said balloon from said collapsed configuration to an expandedconfiguration so that a portion of the selected internal body organ ortissue is sandwiched between said balloon and said disk, thereby atleast temporarily closing the opening.
 2. The method defined in claim 1wherein said rod-like member is hollow and takes the form of a tube,further comprising the step of applying suction to said tube uponcompletion of said step of inflating.
 3. The method defined in claim 2,further comprising the step of crimping said tube upon completion ofsaid step of applying suction.
 4. The method defined in claim 3, furthercomprising the step of severing said tube proximally of said balloonupon completion of said step of crimping.
 5. The method defined in claim1, further comprising the step of severing said rod-like memberproximally of balloon upon completion of said step of inflating.
 6. Themethod defined in claim 1, further comprising the step of inserting intoa patient's abdominal cavity, through an aperture in an abdominal wallof a patient, a distal portion of said rod-like member prior to the stepof inserting the distal end of said rod-like member and said balloonthrough an opening in a selected internal body organ or tissue of thepatient.